Department of Defense Lupus Transformative Vision Award

The TVA supports applications that will fulfill an extraordinary vision for dramatically improving the quality of life of persons with lupus using an intervention at the individual and/or healthcare system level. This award requires a plan that will test and achieve the vision through the translation of research ideas which, when addressed, will result in a near-term impact on the quality of life of persons living with lupus. Applications may address various quality-of-life issues in lupus patients of any age, including but not limited to those with disproportionate health burdens. Preliminary data are required. Human subject research and clinical trials are allowed under this program announcement.

The following are important aspects of the Transformative Vision Award:

• Impact: The proposed research, if successful, should have a major impact on the quality of life of lupus patients. Applications should clearly and explicitly describe the potential impact(s) of the proposed study for individuals living with lupus and to convey its level of significance. The TVA supports high-risk, high-reward studies that have an intervention with the potential to make a significant, near-term impact on the quality of life of lupus patients.

• Research Strategy: The scientific rationale and experimental methodology should demonstrate critical understanding and in-depth analysis of lupus. Experimental strategies may be novel or may be based on strong rationale derived from a literature review.

• Focus Areas: The proposed research must address the FY21 LRP Focus Area for the TVA.

• Research Team: The research team’s background should be appropriate with respect to its ability to successfully complete the proposed work.

• Consumer Advocate: Applications are required to include consumer advocate involvement. The research team must include one or more consumer advocate(s), who will be integral throughout the planning and implementation of the research project. Consumer advocates should be involved in the development of the research question, project design, oversight, recruitment, and evaluation, as well as other significant aspects of the proposed project. Interactions with other team members should be well integrated and ongoing, not limited to attending seminars and semi-annual meetings. As lay representatives, the consumer advocates must be individuals who have been diagnosed with lupus or a caregiver, and they should be active in a lupus advocacy organization. Their role in the project should be independent of their employment, and they cannot be employees of any of the organizations participating in the application. Their role should be focused on providing objective input on the research and its potential impact for individuals with, or at risk for, lupus. The consumer advocate(s) should have a high level of knowledge of current lupus issues and the appropriate background or training in lupus research to contribute to the project.

• Budget: The proposed budget should be appropriate for the proposed research and within the limitations of this program announcement.

Animal research is not allowed under this program announcement.

The proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the American public.

Partnering Principal Investigator (PI) Option:

The Transformative Vision Award encourages applications that include meaningful and productive collaborations between investigators. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI(s) will be identified as a Partnering PI(s), with a maximum of two Partnering PIs. All PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, Statement of Work (SOW), and other required components. If recommended for funding, each PI will be named to an individual award within the recipient organization. For individual submission requirements for the Initiating and Partnering PI, refer to Section II.D.2, Content and Form of the Application Submission.

The types of awards made under the program announcement will be assistance agreements. An assistance agreement is appropriate when the federal government transfers a “thing of value” to a “state, local government,” or “other recipient” to carry out a public purpose of support or stimulation authorized by a law of the United States instead of acquiring property or service for the direct benefit and use of the U.S. government. An assistance agreement can take the form of a grant or cooperative agreement. The level of involvement on the part of the Department of Defense (DOD) during project performance is the key factor in determining whether to award a grant or cooperative agreement. If “no substantial involvement” on the part of the funding agency is anticipated, a grant award will be made (31 USC 6304). Conversely, if substantial involvement on the part of the funding agency is anticipated, a cooperative agreement will be made (31 USC 6305), and the award will identify the specific substantial involvement. Substantial involvement may include, but is not limited to, collaboration, participation, or intervention in the research to be performed under the award. The award type, along with the start date, will be determined during the negotiation process.

The anticipated total costs budgeted for the entire period of performance for an FY21 LRP Transformative Vision Award will not exceed $2,500,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.

Awards will be made no later than September 30, 2022. For additional information refer to Section II.F.1, Federal Award Notices.

The CDMRP expects to allot approximately $2.5M to fund approximately one Transformative Vision Award application. Funding of applications received is contingent upon the availability of federal funds for this program as well as the number of applications received, the quality and merit of the applications as evaluated by scientific and programmatic review, and the requirements of the government. Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds. It is anticipated that awards made from this FY21 funding opportunity will be funded with FY21 funds, which will expire for use on September 30, 2027.